Regulatory PathRegulatory requirements compared

Active substance

Nitrous oxide

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
NITROUS OXIDE, USPN/Agas · inhalationAIR LIQUIDE AMERICA SPECIALITY GASESPrescription16 Jun 2013
NITROUS OXIDE, USPN/Agas · inhalationNITROUS OXIDE CORPPrescription3 Sep 2013
NITROUS OXIDE, USPN/Agas · inhalationNITROUS OXIDE OF CANADAPrescription6 Sep 2013
NITROUS OXIDE, USPN/Agas · inhalationSTRATA MEDICAL INNOVATIONSPrescription25 Nov 2014
NITROUS OXIDE, USPN/Agas · inhalationMATHESON TRI-GAS INCPrescription9 Jan 2017
NITROUS OXIDE, USPN/Agas · inhalationPRAXAIR DISTRIBUTION INCPrescription6 Mar 2017
NITROUS OXIDE, USPN/Agas · inhalationLINDE GAS EQUIPPrescription9 Aug 2026

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
NITROUS OXIDE 100%00572845100 %GAS · INHALATIONAIR LIQUIDE CANADA INC.
NITROUS OXIDE U.S.P.0215481199 %GAS · INHALATIONMESSER CANADA INC.
NITROUS OXIDE USP0201446799 %GAS · INHALATIONLINDE CANADA INC.

WHO WHO Model List of Essential Medicines (2025)

  • 1.1.1. General anaesthetics and oxygen > Inhalational medicines · core
    Anaesthetics and therapeutic gases
    Respiratory > Inhalation:

Safety signals and safety-related labeling changes

All safety entries for nitrous oxide →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.